SchizophreniaNCT02950571
RCT Examining the Effectiveness of Digital Picture Frame Use in Inpatient Setting
A study testing Digital Picture Frame in people with Schizophrenia and Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study will be a randomized controlled trial that investigates the effectiveness of digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards servicing schizophrenia clients at CAMH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Psychosis, Psychosis NOS
- What is being tested?
- Digital Picture Frame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will have severe mental illness (SMI) defined as diagnosis with a major mental illness (in practice, will be primarily schizophrenia spectrum) and inherent to hospital admission will be substantive contact with services and disability affecting day-to-day functioning (Ruggeri, Leese, Thornicroft, Bisoffi, \& Michelle, 2000).
- Admitted to a CAMH inpatient unit, specifically units 2-2 and 2-3, with an anticipated length of stay of 4 weeks or more, as determined by the clinical team
- Chart diagnosis of a major mental illness
- Determined appropriate for study by staff psychiatrist and clinical team (capacity to consent confirmed, no precautions against having the device in the participant's room indicated)
- 18 years of age or older
- Proficiency in English
Who cannot join
- Do not meet the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Examining the Effectiveness of Digital Picture Frame Use on the Long Term Inpatient Experience
This study will be a randomized controlled trial that investigates the effectiveness of digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards servicing schizophrenia clients at CAMH. The effects on client experience will consider the domains of self-concept, interactions with healthcare staff, perception of space, and implications for the recovery process. The comparison of inpatient client experience with DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine the effectiveness of this type of environmental adaptation. This trial builds upon earlier work that demonstrated the feasibility of DPFs in this context.
Read the detailed description
Long term stays in mental health facilities have been shown to have unique challenges and implications. To a considerable extent these challenges grow out of the stigmatized nature of severe mental illnesses (SMI) such as schizophrenia. The social and self-stigma surrounding SMI can have major effects on those affected including decreased self-esteem, self-deprecation, and the development of a self-concept defined by the illness. When stigmatized interpretations of mental illness are internalized, those affected can find it very challenging to sustain non-illness identities and can ultimately result in the loss of non-illness related aspects of self-concept. Inpatient contexts are particularly challenging in this regard, with non-illness oriented identities very difficult to sustain given considerations of power differentials with providers, the reduction of autonomy and choice, and the removal of the individual from environments that are demonstrative of non-illness aspects of self.
Accordingly, a randomized controlled trial design will be used to consider the question: Does having a DPF in psychiatric inpatient unit rooms lead to improvements in interactions with the clinical team, perceptions of enhanced quality of physical space, and an improvement in the sustaining of non-illness aspects of self-concept? While the promising feasibility study findings might suggest hypotheses of improvement in these domains, we will consider this study exploratory given the complex environments inpatient units represent in the study of care quality and outcomes and the modest scope of this intervention. Finally, we will continue to collect feasibility data qualitatively, to inform further refinement of metrics and otherwise consider enhancements in intervention and research design.
- Conditions
- Schizophrenia, Psychosis, Psychosis NOS
- Being tested
- Digital Picture Frame, Standard Care
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Picture FrameBehavioural
The intervention is the provision of digital picture frames in long stay inpatient rooms in a ward at CAMH.
Standard CareBehavioural
High level of support from an interdisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Routine care is comprised of a high level of support from an interdisciplinary team with access to unit-specific and centralized programming Receives: Behavioral: Standard Care |
| Digital Picture Frames | Experimental | Setup: Over 1-2, approximately 30 minute meetings pictures will be uploaded onto the device from picture files provided by the participant and/or their family or an open online source (e.g., Google Images) that are relevant and of interest to the participant.
Installation: The picture frames are secured to a surface in the participant's room (most typically a table) by facilities staff. Participants are instructed in its use.
Check in: At midpoint (2 weeks) an RA will check in with the participant to informally discuss whether or not it continues to work, is being used, and if they want more pictures uploaded. If the latter is requested step 1 will be repeated. Receives: Behavioral: Digital Picture Frame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
To examine the degree to which inpatient staff are perceived as recognizing the individuality of the individual and engage in a hopeful and holistic manner. 4 items from the patient version will be used (1-5 point Likert scale).
Measured: Baseline and after 4 weeks (post intervention)
Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson et al., 1995)
Investigators will only use the general satisfaction question from this measure (1-5 point Likert scale). Only participants in the intervention arm will complete this question.
Measured: After 4 weeks (post intervention)
Change in Empowerment Scale (Rogers et al., 1997)
Measures dimensions of self efficacy, self stigma and self concept (1-9 point Likert scale).
Measured: Baseline and after 4 weeks (post intervention)
Change in Modified Engulfment Scale (McCay & Seeman, 1998)
Only two items from this measure focussing specifically on self-concept will be used (1-5 point Likert scale).
Measured: Baseline and after 4 weeks (post intervention)
Change in Rosenberg Self-Esteem Scale (Rosenberg, 1965)
The broadest reaching and high factor loading item, 'On the whole I am satisfied with myself' will be used (1-4 point Likert scale).
Measured: Baseline and after 4 weeks (post intervention)
Change in Scale to Assess Therapeutic Relationship (STAR; Mcguire-Snieckus et al., 2007)
Three items assessing common factors in the therapeutic relationship with the clinical team are from the scale will be used (1-5 point Likert scale).
Measured: Baseline and after 4 weeks (post intervention)
Change in Satisfaction with the physical environment of the inpatient unit
One question developed my investigators due to lack of standardized measures to specifically measure participant satisfaction with the physical environment of the inpatient unit (1-5 point Likert scale)
Measured: Baseline and after 4 weeks (post intervention)
Change in Satisfaction with the rooms on the inpatient unit
One question developed by investigators due to lack of standardized measures to specifically measure participant satisfaction with their room on the inpatient unit (1-5 point Likert scale)
Measured: Baseline and after 4 weeks (post intervention)
Semi structured interviews
SC participants will be asked broad questions about how satisfied they were with the inpatient unit space and what might be improved. These same questions will be asked of DPF participants, but will be followed by questions specific to the DPF support.
Measured: After 4 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
- Investigators
- Sean A Kidd, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950571
- Sponsor's protocol ID
- 074/2016
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Connell M, Tondora J, Croog G, Evans A, Davidson L. From rhetoric to routine: assessing perceptions of recovery-oriented practices in a state mental health and addiction system. Psychiatr Rehabil J. 2005 Spring;28(4):378-86. doi: 10.2975/28.2005.378.386.
PubMed 15895922Attkisson, C. C., & Greenfield, T. K. (1995). The Client Satisfaction Questionnaire (CSQ) scales. Outcome assessment in clinical practice. Baltimore, MD: Williams & Wilkins, 2-10.
Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
PubMed 9255837McCay EA, Seeman MV. A scale to measure the impact of a schizophrenic illness on an individual's self-concept. Arch Psychiatr Nurs. 1998 Feb;12(1):41-9. doi: 10.1016/s0883-9417(98)80007-1.
PubMed 9489173Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61.
McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
PubMed 17094819
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Examining the Effectiveness of Digital Picture Frame Use on the Long Term Inpatient Experience
- ClinicalTrials.gov ID
- NCT02950571
- Acronym / sponsor ID
- 074/2016
- Conditions
- Schizophrenia, Psychosis, Psychosis NOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized controlled trial that investigates the effectiveness of digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards servicing schizophrenia clients at CAMH. The effects on client experience will consider the domains of self-concept, interactions with healthcare staff, perception of space, and implications for the recovery process. The comparison of inpatient client experience with DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine the effectiveness of this type of environmental adaptation. This trial builds upon earlier work that demonstrated the feasibility of DPFs in this context.
Detailed description
Long term stays in mental health facilities have been shown to have unique challenges and implications. To a considerable extent these challenges grow out of the stigmatized nature of severe mental illnesses (SMI) such as schizophrenia. The social and self-stigma surrounding SMI can have major effects on those affected including decreased self-esteem, self-deprecation, and the development of a self-concept defined by the illness. When stigmatized interpretations of mental illness are internalized, those affected can find it very challenging to sustain non-illness identities and can ultimately result in the loss of non-illness related aspects of self-concept. Inpatient contexts are particularly challenging in this regard, with non-illness oriented identities very difficult to sustain given considerations of power differentials with providers, the reduction of autonomy and choice, and the removal of the individual from environments that are demonstrative of non-illness aspects of self.
Accordingly, a randomized controlled trial design will be used to consider the question: Does having a DPF in psychiatric inpatient unit rooms lead to improvements in interactions with the clinical team, perceptions of enhanced quality of physical space, and an improvement in the sustaining of non-illness aspects of self-concept? While the promising feasibility study findings might suggest hypotheses of improvement in these domains, we will consider this study exploratory given the complex environments inpatient units represent in the study of care quality and outcomes and the modest scope of this intervention. Finally, we will continue to collect feasibility data qualitatively, to inform further refinement of metrics and otherwise consider enhancements in intervention and research design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareRoutine care is comprised of a high level of support from an interdisciplinary team with access to unit-specific and centralized programming |
| Digital Picture Frames | Experimental | Behavioral: Digital Picture FrameSetup: Over 1-2, approximately 30 minute meetings pictures will be uploaded onto the device from picture files provided by the participant and/or their family or an open online source (e.g., Google Images) that are relevant and of interest to the participant. Installation: The picture frames are secured to a surface in the participant's room (most typically a table) by facilities staff. Participants are instructed in its use. Check in: At midpoint (2 weeks) an RA will check in with the participant to informally discuss whether or not it continues to work, is being used, and if they want more pictures uploaded. If the latter is requested step 1 will be repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants will have severe mental illness (SMI) defined as diagnosis with a major mental illness (in practice, will be primarily schizophrenia spectrum) and inherent to hospital admission will be substantive contact with services and disability affecting day-to-day functioning (Ruggeri, Leese, Thornicroft, Bisoffi, \& Michelle, 2000).
- Admitted to a CAMH inpatient unit, specifically units 2-2 and 2-3, with an anticipated length of stay of 4 weeks or more, as determined by the clinical team
- Chart diagnosis of a major mental illness
- Determined appropriate for study by staff psychiatrist and clinical team (capacity to consent confirmed, no precautions against having the device in the participant's room indicated)
- 18 years of age or older
Key exclusion criteria (1 listed)
- Do not meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Picture FrameThe intervention is the provision of digital picture frames in long stay inpatient rooms in a ward at CAMH. | Behavioural | Digital Picture Frames |
| Standard CareHigh level of support from an interdisciplinary team. | Behavioural | Standard Care |
Primary outcome
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
Time frame: Baseline and after 4 weeks (post intervention)
To examine the degree to which inpatient staff are perceived as recognizing the individuality of the individual and engage in a hopeful and holistic manner. 4 items from the patient version will be used (1-5 point Likert scale).
Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson et al., 1995)
Time frame: After 4 weeks (post intervention)
Investigators will only use the general satisfaction question from this measure (1-5 point Likert scale). Only participants in the intervention arm will complete this question.
Change in Empowerment Scale (Rogers et al., 1997)
Time frame: Baseline and after 4 weeks (post intervention)
Measures dimensions of self efficacy, self stigma and self concept (1-9 point Likert scale).
Change in Modified Engulfment Scale (McCay & Seeman, 1998)
Time frame: Baseline and after 4 weeks (post intervention)
Only two items from this measure focussing specifically on self-concept will be used (1-5 point Likert scale).
Change in Rosenberg Self-Esteem Scale (Rosenberg, 1965)
Time frame: Baseline and after 4 weeks (post intervention)
The broadest reaching and high factor loading item, 'On the whole I am satisfied with myself' will be used (1-4 point Likert scale).
Change in Scale to Assess Therapeutic Relationship (STAR; Mcguire-Snieckus et al., 2007)
Time frame: Baseline and after 4 weeks (post intervention)
Three items assessing common factors in the therapeutic relationship with the clinical team are from the scale will be used (1-5 point Likert scale).
Change in Satisfaction with the physical environment of the inpatient unit
Time frame: Baseline and after 4 weeks (post intervention)
One question developed my investigators due to lack of standardized measures to specifically measure participant satisfaction with the physical environment of the inpatient unit (1-5 point Likert scale)
Change in Satisfaction with the rooms on the inpatient unit
Time frame: Baseline and after 4 weeks (post intervention)
One question developed by investigators due to lack of standardized measures to specifically measure participant satisfaction with their room on the inpatient unit (1-5 point Likert scale)
Semi structured interviews
Time frame: After 4 weeks (post intervention)
SC participants will be asked broad questions about how satisfied they were with the inpatient unit space and what might be improved. These same questions will be asked of DPF participants, but will be followed by questions specific to the DPF support.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Background: PubMed 15895922O'Connell M, Tondora J, Croog G, Evans A, Davidson L. From rhetoric to routine: assessing perceptions of recovery-oriented practices in a state mental health and addiction system. Psychiatr Rehabil J. 2005 Spring;28(4):378-86. doi: 10.2975/28.2005.378.386.
- BackgroundAttkisson, C. C., & Greenfield, T. K. (1995). The Client Satisfaction Questionnaire (CSQ) scales. Outcome assessment in clinical practice. Baltimore, MD: Williams & Wilkins, 2-10.
- Background: PubMed 9255837Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
- Background: PubMed 9489173McCay EA, Seeman MV. A scale to measure the impact of a schizophrenic illness on an individual's self-concept. Arch Psychiatr Nurs. 1998 Feb;12(1):41-9. doi: 10.1016/s0883-9417(98)80007-1.
- BackgroundRosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61.
- Background: PubMed 17094819McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teachings hospital.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean A Kidd, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Picture Frame in people with Schizophrenia and Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005) (time frame: Baseline and after 4 weeks (post intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950571, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.